FDA has previously introduced the concept of “predetermined change control plans” for adaptive machine learning-based devices. Legislation that is now part of the Senate user fee bill is intended to encourage the agency to apply that approach—where predefined modifications don’t require new submissions—more routinely, and not just for software.Read Article
20 Years of Experience
@MedtechDavid, Executive Editor of MedTech Strategist Market Pathways has been covering the medical technology sector as a writer and editor for about 20 years. David specializes in the regulatory and reimbursement dynamics that impact device and diagnostics companies' ability to succeed in the marketplace. He joined MedTech Strategist in 2019 to launch Market Pathways as the premier publication covering policy and market access issues in medtech.
David previously served as the executive editor/editor-in-chief of The Gray Sheet and Medtech Insight, and he spent years as a writer for The Gray Sheet, reporting on policies impacting the device industry from FDA, CMS, OIG, Europe, and elsewhere around the world. He frequently talks to leaders in government and industry and enjoys digging into the details of developing healthcare policies to understand how they will play out in the market. Earlier in his career, David was an editor with the American Chemical Society, where he analyzed issues for professionals in the pharmaceutical industry and analytical instrumentation space. He has also worked in the drug industry and has a degree in chemistry.